510(k) Report

Devices descending from K950069

190 later devices reach Dasher-14 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K081465Axium Detachable Coil SystemMicro Therapeutics, Inc.2008222
+7K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)MicroVention, Inc.20220—
+7K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL…Medos International SARL20220Class I
+7K211344MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini…Medos International SARL20211—
+7K210638i-ED COIL SystemKaneka Medical America, LLC20210—
+7K192955Penumbra LP Coil SystemPenumbra, Inc.20191—
+7K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+7K173614Penumbra Coil 400, Ruby Coil System, POD SystemPenumbra, Inc.20181—
+7K172390Optima Coil SystemBlockade Medical, LLC (D.B.A. Balt Usa)201874
+7K171862GALAXY G3 Mini Microcoil Delivery SystemCodman & Shurtleff, Inc.201721
+7K170852POD Packing CoilPenumbra, Inc.20170—
+7K171747MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch…Codman & Shurtleff, Inc.20172—
+7K162524AZUR CX Detachable 18 Peripheral Coil SystemMicroVention, Inc.20171—
+7K162704Axium Prime Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20174—
+7K161367HydroCoil Embolic System (HES)MicroVention, Inc.201604
+7K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc.201601
+7K153658Target Detachable CoilsStryker Neurovascular20161128
+7K160832Penumbra Smart CoilPenumbra, Inc.20162—
+7K151780CAAS WorkstationPie Medical Imaging BV20169—
+7K160096InZone Detachment SystemStryker Neurovascular20168—
+7K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc.2016116
+7K151447Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20155—
+7K151572Penumbra Smart CoilPenumbra, Inc.20153—
+7K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20154—
+7K143044CAAS A-ValvePie Medical Imaging BV20150—
+7K142239CPS Direct MediGuide Enabled outer catheterSt Jude Medical20140—
+7K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.20142—
+7K142254CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel…St Jude Medical20140—
+7K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20145—
+7K133310Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20146—
+7K133626Azur Pure Peripheral Coil System, Pushable 35MicroVention, Inc.20130—
+7K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation20136—
+7K132083Azur Pure Peripheral Coil Systems, Pushable 35MicroVention, Inc.20130—
+7K132317Microplex Coil System (MCS), VFCMicroVention, Inc.201302
+7K122316Azur Detachable 35MicroVention, Inc.20120—
+7K103758Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10MicroVention, Inc.201171
+7K102365Microplex Coil System- CosmosMicroVention, Inc.20103—
+7K100454Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V…MicroVention, Inc.20109—
+7K093358Microplex Coil System-Cosmos, Models 81451CS-V, 181555CS-V, 16=81652CS-VMicroVention, Inc.201022—
+7K090046Concerto Detachable Coil SystemMicro Therapeutics, Inc.20093—
+8K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…Cerenovus, Inc.20260—
+8K250079Ruby XL SystemPenumbra, Inc.20250—
+8K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+8K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc.20243Class I
+8K242243Target Detachable CoilsStryker Neurovscular20242—
+8K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc.20243Class I
+8K230284Penumbra LP Coil SystemPenumbra, Inc.20230—
+8K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+8K222533Target Tetra Detachable CoilsStryker Neurovascular20223—
+8K213200Solus Gold Embolization DeviceArtio Medical, Inc.20220—
+8K212455InZone Detachment SystemStryker Neurovascular202111
+8K203625Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20213—
+8K203432Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular202111
+8K202850Concerto Versa, Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20212—
+8K191680AZUR Vascular PlugMicroVention, Inc.20200—
+8K200030Optima Coil SystemBalt USA, LLC202065
+8K180653Spartan eCoil SystemSpartan Micro, Inc.20180—
+8K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+8K173711Wallaby Avenir Coil SystemWallaby Medical, Inc.20180—
+8K180019CAAS WorkstationPie Medical Imaging BV20188—
+8K161429Target Detachable CoilsStryker Neurovascular201610—
+8K150402Endoluminal Occlusion System-EOSArtventive Medical Group, Inc.20151—
+8K112181Hydrocoil (R) Embolic System (Hes)MicroVention, Inc.20110—
+9K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+9K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+9K253511Concerto Versa™ Detachable CoilMedtronic, Inc.20261—
+9K252694Target Detachable CoilStryker Neurovascular20251—
+9K251355X1-FFRSpectrawave, Inc.20250—
+9K251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular20250—
+9K232147CAAS WorkstationPie Medical Imaging BV20241—
+9K232955Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20242—
+9K233420Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20230—
+9K223386Optima Coil SystemBalt USA, LLC202231
+9K220699Prestige Coil SystemBait USA, LLC202212
+9K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc.20220—
+9K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+9K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+10K261772Target Xtra Detachable CoilStryker Neurovscular20260—
+10K261866Concerto Versa™ Detachable CoilMedtronic, Inc.20260—
+10K251383Prestige Coil System (Prestige Packing Line Extension)Balt USA, LLC20250—
+10K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+10K243769QFR (3.0)Qfr Solutions BV20250—
+10K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20241—
+10K242582Optima Coil System (OptiBlock Line Extension)Balt USA, LLC20242—
+10K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+11K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20260—
+11K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC20251—
+11K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+11K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+12K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC20260—